MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 3-0 D/A V-7; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3976H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The suture deswaged during routine use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported performance pull off suture needle.It was received for analysis an empty opened labeled winding former and two detached needles of product code (b)(4), lot mgj621.This product code is double armed.During the visual inspection of detached needles, the swage and attachment area were noted to be as expected and marks could be observed on the body of the needles that appear to be by use of a surgical instrument.No suture remnant was observed into the barrel holes and the suture was not received to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRNVA BLU 36IN 3-0 D/A V-7
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9291297
• Report Number: 2210968-2019-89672
• Device Sequence Number: 2003370
• Product Code: GAW
• UDI-Device Identifier: 10705031005129
• UDI-Public: 10705031005129
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 3976H
• Device Lot Number: MGJ621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Received by Manufacturer: 10/12/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1